Nalgezin® (Nalgesin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsp

tablets, film-coated.

Composition:

1 tablet, film-coated, contains:

CORE

Active substance: Naproxen sodium 275.00 mg

Excipients: povidone 12.0 mg, cellulose microcrystalline 97.00 mg, talcum powder 15.0 mg, magnesium stearate 3.00 mg, purified water 18.00 mg

SHELL

Dye ospray YS-1-4215 15.00 mg Opadry YS-1-4215 - this is ready for use a mixture of titanium dioxide (E171), macrogol, dye indigocarmine E132 and hypromellose, weighed together.

Description:

Oval biconvex tablets covered with a film coating of blue color.

Pharmacotherapeutic group:nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:

Nalgezin, a drug of naproxen, has an analgesic, antipyretic and anti-inflammatory effect. The mechanism of action is associated with a non-selective inhibition of cyclooxygenase 1 and 2 (COX-1, COX-2) activity. Tablets, film-coated, Nalgezin are readily soluble, rapidly absorbed from the gastrointestinal tract and provide a rapid onset of the analgesic effect.

Pharmacokinetics:

Absorption from the gastrointestinal tract - fast and complete, bioavailability - 95% (eating practically does not affect either the completeness or the rate of absorption).The time to reach the maximum concentration is 1-2 hours, the connection with plasma proteins> 99%, the half-life is 12-15 hours. Metabolism is in the liver to dimethylnaproxen with the participation of the enzyme system CYP2C9. Clearance - 0.13 ml / min / kg. It is excreted 98% by the kidneys, 10% of them are excreted unchanged; with bile - 0.5-2.5%. The equilibrium concentration is determined by taking 4-5 doses of the drug (2-3 days). With renal failure, metabolites can be accumulated.

Indications:

- Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease), gouty arthritis, rheumatic soft tissue damage, osteoarthrosis of the peripheral joints and spine, including radicular syndrome, tendovaginitis, bursitis).

- Pain syndrome of mild or moderate severity: neuralgia, ossalgia, myalgia, lumboschialgia, posttraumatic pain syndrome (sprains and bruises), accompanied by inflammation, postoperative pain (in
traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, algodismenorea, adnexitis, toothache.

- In the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis).

- Feverish syndrome with "colds" and infectious diseases.

Nalgezin is used for symptomatic therapy (to reduce pain, inflammation and decrease in elevated body temperature) and does not affect the progression of the underlying disease.

Contraindications:

- Hypersensitivity to naproxen or naproxen sodium; with anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

- Period after aortocoronary bypass surgery;

- Erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding;

- Inflammatory bowel disease, in the phase of exacerbation (Nonspecific ulcerative colitis (NJC), Crohn's disease);


- Cerebrovascular bleeding or other bleeding and hemostasis disorders;

- Severe hepatic impairment or active liver disease;

- Severe renal insufficiency (creatinine clearance less than 20 ml / min), including confirmed hyperkalemia, progressive kidney disease;

- Oppression of bone marrow hematopoiesis;

- Pregnancy, the period of breastfeeding;

- One Nalgezin tablet contains 275 mg of naproxen, so the drug is not recommended for children under 9 years of age and / or weighing less than 27 kg.

Carefully:

Ischemic heart disease, cerebrovascular disease, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min; anamnestic data on the development of ulcerative lesions of the gastrointestinal tract (GIT), the presence of infection Helicobacter pylori, old age, prolonged use of NSAIDs, frequent alcohol use, severe physical illness, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticoids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline). To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used as little as possible. Children aged 9 to 12 years, the drug is prescribed only on the advice of a doctor.

Pregnancy and lactation:

Nalgezin is not recommended for use during pregnancy and lactation.

Dosing and Administration:

Inside. Tablets should be taken with a sufficient amount of water. Follow the doctor's instructions strictly. You should not stop treatment or change your dosage without first consulting a doctor.

Ask the doctor the duration of the drug.



Recommended therapy scheme:
The usual daily dose used to relieve pain is 2-4 tablets (550 - 1100 mg).

With very severe pain and no history of gastrointestinal diseases, a doctor can increase the daily dose to 6 tablets (1650 mg), but not more than 2 weeks.

When using the drug as an antipyretic agent, the initial dose is 2 Nalgesine tablets, then 1 tablet of Nalgesine (275 mg) is taken every 6-8 hours.

To prevent migraine attacks, 2 tablets (550 mg) are recommended twice a day. However, treatment should be discontinued if the frequency, intensity and duration of migraine attacks do not decrease within 4-6 weeks. At the first sign of a migraine attack, you should take 3 tablets (825 mg), and if necessary 1-2 tablets (275 - 550 mg) after 30 minutes.

To facilitate menstrual pains and spasms, pain after injection of IUD (intrauterine spiral) and other gynecological pains, it is recommended that the drug be administered at an initial dose of 2 tablets (550 mg), then 1 tablet (275 mg) every 6-8 hours.

In an acute gout attack, the initial dose is 3 tablets (825 mg), then 2 tablets (550 mg) after 8 hours, and then 1 tablet (275 mg) every 8 hours until the seizure stops.

In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the usual initial dose of the drug is from 2 -4 tablets (550-1100 mg), twice daily in the morning and in the evening. The initial daily dose, ranging from 3 (825 mg) to 6 tablets (1,650 mg) is recommended for patients with severe night pain and / or severe morning stiffness,transferred to treatment with naproxen sodium with high doses of other non-steroidal anti-inflammatory drugs, and patients whose pain is the leading symptom. Usually the daily dose is 2 tablets (550 mg) - 4 tablets (1100 mg), administered in two divided doses.

Morning and evening doses may not be the same. With the consent of the attending physician, you can change them depending on the prevalence of symptoms, i.e. night pain and / or morning stiffness.

Children older than 9 years and / or weighing more than 27 kg recommended daily dose of 10 mg / kg in 1-2 divided doses.

If you get the impression that the effect of the drug is very strong or weak, inform your doctor or pharmacist.

Side effects:

Side effects are most frequent when using high doses of Nalgezin:

- from the digestive system: constipation, abdominal pain, indigestion, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and bleeding of the gastrointestinal tract, increased activity of "liver" enzymes, impaired liver function, jaundice, bloody vomiting, melena;

- from the central nervous system: hearing loss, dizziness, headache, drowsiness,depression, sleep disorders, inability to concentrate, insomnia, malaise, myalgia and muscle weakness, slowing reaction rate, aseptic meningitis, cognitive dysfunction;

- from the skin: itching, ecchymosis, increased sweating, purpura, alopecia, photodermatosis;

- on the part of the bodies: tinnitus, visual impairment, hearing impairment;

- from the cardiovascular system: puffiness, shortness of breath, palpitations, congestive heart failure, vasculitis;

- from the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual irregularities;

- from the hemopoietic organs: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia;

- from the respiratory system: eosinophilic pneumonitis;

- allergic reactions: skin rashes, hives, angioedema,

epidermal necrosis, erythema multiforme, Stevens-Johnson syndrome;

- other: thirst, hyperthermia, hyperglycemia, hypoglycemia, hemolytic anemia.

If you notice such a phenomenon, stop taking the medication and, if possible, consult your doctor.

Overdose:

A considerable overdose may be characterized by drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability, and in severe cases - hematemesis, melena, disturbance of consciousness, convulsions and renal failure).

A patient who accidentally or intentionally has a large amount of Nalgezin should rinse the stomach and perform symptomatic therapy: Activated carbon, antacids, blockers H2 receptors, proton pump inhibitors. Hemodialysis is ineffective.

Interaction:

When treating anticoagulants, it should be borne in mind that naproxen can increase bleeding time. Do not use the drug simultaneously with other NSAIDs (increased risk of side effects).

Patients who simultaneously receive hydantoins, anticoagulants, or other medications that bind to a large extent with plasma proteins should monitor signs of potentiation of the action or overdose of these drugs.

The drug Nalgezin can reduce the antihypertensive effect of propranolol and other beta-blockers, and may increase the risk of renal failure associated with the use of ACE inhibitors. Under the action of naproxenum, natriuretic action of furosemide is inhibited. Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in the plasma. The use of probenecid increases the level of naproxen in plasma. Cyclosporin increases the risk of developing kidney failure.

Naproxen slows the excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of developing their toxic effects.

Antacid preparations containing magnesium and aluminum reduce the absorption of naproxen.

Special instructions:

Do not exceed the dosage indicated in the instructions. To reduce the risk of developing adverse events from the gastrointestinal tract (GIT), a minimum effective dose should be used with the minimum possible short course.

If pain and fever persists or worsens, you should consult your doctor. Patients with bronchial asthma, with disorders of blood coagulability,as well as patients with increased sensitivity to other analgesics before taking Nalgezin should consult a doctor.

Caution should be given to patients with liver disease and kidney failure. In patients with renal insufficiency, it is necessary to monitor the level of creatinine clearance. At a creatinine clearance level below 20 ml / min: prescribe naproxen Not recommended. In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen is increased, so such patients lower doses are recommended.

Nalgezin should not be taken with other anti-inflammatory and analgesic drugs, except for doctor's prescriptions.

Older patients are also recommended lower doses.

You should avoid taking naproxen within 48 hours before surgery. If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the test. Similarly, naproxen can affect the determination of 5-hydroxyindoleacetic acid in urine.

The use of naproxen, as well as other drugs that block the synthesis of prostaglandins, can affect fertility,so it is not recommended for women who want to become pregnant.

Each Nalgezin tablet contains approximately 25 mg of sodium. If you limit salt intake, this must be taken into account.

Effect on the ability to drive transp. cf. and fur:

Naproxen slows the reaction rate in patients. This should be taken into account when driving a car and performing tasks that require special attention.

Form release / dosage:

Film-coated tablets, 275 mg.

10 tablets in a blister pack made of PVC / aluminum foil. By 1 or 2 blister in a pack of cardboard along with instructions for use.

Packaging:blisters (1) -tacks, cardboard (10)
blisters (2), cardboard tacks
Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years. Do not use a drug after the expiry date.

Terms of leave from pharmacies:On prescription
Registration number:П N014103 / 01
Date of registration:03.04.2008
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
KRKA, d.d. Slovenia
Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Information update date: & nbsp31.07.2014
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